PEPGEN P-15

Description of Event or Problem

IT WAS REPORTED THAT PEPGEN P-15 PARTICULATE MIXED WITH DBX PUTTY WAS USED SIMULTANEOUSLY WITH IMPLANT PLACEMENT IN THE LOWER RIGHT POSTERIOR EDENTULOUS MANDIBLE (A HEALED EXTRACTION SITE) WITH REPORTED BONE QUALITY TYPE II; HEALING WAS TRANSGINGIVAL. THE IMPLANT DID NOT OSSEOINTEGRATE AND HAD CLINICAL MOBILITY PRIOR TO EXPLANTATION AT TWENTY DAYS POST-PLACEMENT. THE PT HAD AN EXISTING COMPLETE LOWER DENTURE WHICH, ACCORDING TO THE DOCTOR, WAS RELIEVED TO MINIMIZE/NEGATE OCCLUSAL LOAD/PRESSURE; THE PT REPORTED NOT WEARING THE DENTURE FOR SEVERAL DAYS. IT IS NOT CLEAR IF THE GRAFT INTEGRATED WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT; HOWEVER, IT IS LIKELY THE GRAFT HAD MINIMAL INTEGRATION AT TWENTY DAYS POST-IMPLANT SURGERY. IT IS ALSO NOT CLEAR WHY GRAFTING WAS PERFORMED (I.E. BONY DEHISCENCE, CORTICAL PLATE FRACTURE DURING OSTEOTOMY PREPARATION).

Additional Manufacturer Narrative

FAILURE TO OSSEOINTEGRATE, WHILE UNCOMMON, IS AN INHERENT RISK OF THE PROCEDURE KNOWN TO DOCTOR AND PT BEFORE THE PROCEDURE IS INITIATED AND IS DEPENDENT ON MANY FACTORS INCLUDING THE PT'S AGE, SEX, HEALTH, AND SOCIAL HISTORY (WHICH APPEARS TO BE UNREMARKABLE), THE TYPE AND SIZE OF THE DEFECT BEING GRAFTED, OCCURRENCE OF SITE PREPARATION TRAUMA (HEAT OR PRESSURE) RESULTING IN NECROSIS OR SCARRING AND FIBROSIS, PRIMARY STABILITY OF THE IMPLANT (SECONDARY TO BONE QUALITY AND/OR EXCESSIVE PREPARATION OF OSTEOTOMY), AND GRAFT PLACEMENT TECHNIQUE. THOUGH PEPGEN WILL REMODEL TO BONE AT SIMILAR RATE AS NATURAL BONE IN A PT, IT IS IMPOSSIBLE TO DETERMINE THE SPECIFIC RESORPTION RATE OF ANY BONE GRAFTING MATERIAL; MATERIAL PLACED IN AN AREA OF LOW VASCULARITY AND LITTLE OSTEOGENIC POTENTIAL WILL TAKE MUCH LONGER TO REMODEL TO BONE THAN IF PLACED IN A MORE ACTIVE SITE. FROM THE INFO PROVIDED, IT IS NOT POSSIBLE TO DETERMINE IF THE IMPLANT OR GRAFT WAS THE ETIOLOGY OF FAILURE, THOUGH IT DOES NOT APPEAR THAT THE GRAFTING MATERIAL MALFUNCTIONED. THE IMPLANT LOSS WILL BE REPORTED VIA ASR, AS APPROPRIATE. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.